BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 1838542 · Received September 18, 2010

    Report

    Report Number
    2015691-2010-14078
    Event Type
    Injury
    Date Received
    September 18, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 20, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. REQUESTS WERE MADE FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION IS ONGOING. THE DEVICE WAS RETURNED FOR EVALUATION, ANALYSIS IS PENDING. THE DEVICE HISTORY RECORD (DHR) REVIEW IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW WAS NOT POSSIBLE DUE TO NO LOT/SERIAL NUMBER WAS PROVIDED, AND DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    SURGEON REPORTED EXPLANTING VALVE DUE SEVERE CALCIFICATION. AT THIS TIME, DEVICE IS STILL WITH PATHOLOGY. IT WILL BE ANOTHER WEEK OR SO, BEFORE IT IS AVAILABLE TO US (EDWARDS LIFESCIENCES). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS ELEVATED ACCUTNI RESULTS WITHIN RISK STRATIFICATION RANGE FOR ONE PATIENT GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE SAMPLE WAS REPEATED AND THE RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Description of Event or Problem · 1

    ON SEPTEMBER 11, 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER DISPLAYS A BATTERY INDICATOR. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT DOES NOT RECALL THE DATE/TIME WHEN THE ALLEGED ISSUE BEGAN. IN ADDITION TO ORAL MEDICATION (TYPE AND DOSE UNSPECIFIED), THE PATIENT STATED HE ALSO MANAGES HIS DIABETES WITH DIET AND/OR EXERCISE; HOWEVER, IT IS NOT KNOWN WHAT ACTION, IF ANY, THE PATIENT TOOK REGARDING HIS DIABETES MANAGEMENT AS A RESULT OF THE REPORTED POWER ISSUE. APPROXIMATELY TWO DAYS LATER, THE PATIENT CLAIMED HE DEVELOPED BLURRY VISION AS A RESULT OF THE ALLEGED METER ISSUE. THE PATIENT, HOWEVER, DENIED RECEIVING ANY MEDICAL INTERVENTION OR TREATMENT FOLLOWING THE REPORTED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE BATTERIES IN THE SUBJECT METER NEEDED TO BE REPLACED, PER OWNER'S MANUAL RECOMMENDATION; HOWEVER, THE CSR NOTED THE PATIENT DID NOT HAVE REPLACEMENT BATTERIES AVAILABLE AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE DEVELOPED A SYMPTOM THAT CAN BE ASSOCIATED WITH A SERIOUS INJURY AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention